Director Quality Assurance & Regulatory CompliancePosted: November 12, 2009
Almac Clinical Technologies is a division of the Almac Group that specializes in interactive technology and service solutions to increase the quality and efficiency of the clinical trial process. Almac’s technologies have been deployed in over 1300 clinical trials, incorporating over 1 million patients in over 80 countries and more than 50 languages.
Our Yardley, PA office is seeking a talented Director for the development and management of the Quality department, ensuring that internal and external customer services provided by the company contain appropriate quality checks and quality oversight and support the professional growth and development of all staff by mentoring as well as increasing overall awareness with regard to the use of quality in processes, practices and methodologies. In addition, the Director develops plans and strategies for sustaining and continuously improving quality related to the company’s business operations and service model, including company infrastructure qualification, disaster recovery and business continuity. Serves as a resource to management, providing reports, analysis, direction or other deliverables as needed. Education:
Bachelor degree
Work Experience:
7+ years of pharmaceutical or clinical research experience
Prior Work Experience:
Minimum 5+ years of pharmaceutical or clinical research experience, software and/or CRO experience is a plus Minimum 3+ years of Quality Assurance experience Experience managing staff and providing guidance/direction to management
Additional:
Demonstrable knowledge of the clinical trial process Knowledge of GCP guidelines Knowledge of Agency guidelines Assist Almac CT’s core management as requested Knowledge of 21CFR Part 11 regulations Knowledge of HIPAA regulations Strong communication skills (written and verbal) Strong interpersonal skills Strong customer service skills Ability to operate in team environment Ability to delegate work and organize teams Strong organizational skills Thorough working knowledge of Microsoft applications Excellent organizational, leadership, decision-making and human relations skills Process optimization certification (ex. Six Sigma, ISO, ASQC)
Great opportunity to join a growing company in the pharma/biotech industry offering attractive work environment and compensation/benefits package including 25 paid vacation days. Please note that we will be relocating to Souderton, PA (Lansdale exit off Rt 476) to our new North Americam Headquarters July 2010 and successful candidate must reside within commuting distance of new location. For immediate consideration, please email corporate recruiter for immediate consideration at tony.roig@almacgroup.com and apply online
|
